Thoracic endovascular grafts recalled over coating scrapings that may embolize
Cook Medical is recalling 695 Zenith Alpha 2 Thoracic Endovascular Grafts because affected devices may contain PTFE coating scrapings that could be released during deployment.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: Scored 5 because the FDA classified this recall as Class I, which the rubric assigns the Critical tier.
Plain-English summary
The Zenith Alpha 2 Thoracic Endovascular Graft, catalog prefix ZTA2, is being recalled across a range of reference part numbers including ZTA2-P-40-117-W, ZTA2-P-40-167, ZTA2-P-42-121 and ZTA2-P-42-173.
Affected devices may contain PTFE coating scrapings. The scrapings could be released during device deployment, potentially causing intravascular embolization.
The recall covers 695 units, distributed domestically across states including Alabama, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah and Virginia. The FDA has classified the recall as Class I.
Facilities should identify affected part and lot numbers, quarantine them and follow Cook Medical's instructions.
The recalled product
- Product
- Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2- Reference Part Numbers ZTA2-P-40-117-W ZTA2-P-40-167 ZTA2-P-40-167-W ZTA2-P-40-217-W ZTA2-P-42-121 ZTA2-P-42-121-W ZTA2-P-42-173 ZTA2-P-42-173-W ZTA2-P-42-225 ZTA2-P-42-225-W ZTA2-P-44-125 ZTA2-P-44-1
- Manufacturer
- Cook Medical Incorporated
- Category
- Medical Device — Vascular graft
- Hazard
- particulate-release
- embolization-risk
- coating-defect
- implant
Distribution
Distributed in 31 states:
- AL
- AR
- AZ
- CA
- CT
- DC
- DE
- FL
- GA
- IL
- IN
- LA
- MA
- MD
- MI
- MN
- MO
- NC
- NJ
- NY
- OH
- OR
- PA
- SC
- TN
- TX
- UT
- VA
- WA
- WI
- WV
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